ICY HOT LIDOCAINE DRY- lidocaine, menthol spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Chattem, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical anesthetic Topical analgesic temporarily relieves minor pain
Authorization status:
OTC monograph not final
Authorization number:
41167-1740-2

ICY HOT LIDOCAINE DRY- lidocaine, menthol spray

Chattem, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Icy Hot Lidocaine Dry Spray

ICY HOT LIDOCAINE DRY SPRAY

Drug Facts

Active ingredients

Purpos es

Lidocaine 4%....................................................................................................................................Topical

anesthetic

Menthol 1%........................................................................................................................................Topical

analgesic

Us e

temporarily relieves minor pain

Warnings

For external use only

Do not use

on large areas of the body or on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

When using this product

■ use only as directed. Read and follow all directions and warnings on this label.

■ do not allow contact with the eyes and mucous membranes

■ rare cases of serious burns have been reported with products of this type

■ do not apply to wounds or damaged, broken or irritated skin

■ avoid spraying on face

■ avoid inhalation of spray

■ do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use

■ do not use at the same time as other topical analgesics

■ a transient burning sensation may occur upon application but generally disappears in several days

■ avoid applying into skin folds

Stop use and ask a doctor if

■ condition worsens

■ redness is present

■ irritation develops

■ symptoms persist for more than 7 days or clear up and occur again within a few days

■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was

applied

Extremely Flammable

■ do not use near heat or flame or while smoking

■ avoid long term storage above 104°F (40°C)

■ do not puncture or incinerate. Contents under pressure.

■ do not store at temperatures above 120°F (49°C)

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 12 years:

■ spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

■ product will dry quickly on its own, and does not need to be rubbed in

children 12 years or younger: ask a doctor

Inactive ingredients:

alcohol denat. (30%), caprylic/capric triglyceride, isobutane, propylene glycol

PRINCIPAL DISPLAY PANEL

MAX STRENGTH LIDOCAINE

ICY HOT

LIDOCAINE

PLUS MENTHOL

SPRAY

NET WT 4 OZ (113 g) Pain Relief Spray

ICY HOT LIDOCAINE DRY

lidocaine, menthol spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4116 7-1740

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

4 g in 10 0 mL

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

1 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

ISO BUTANE (UNII: BXR49 TP6 11)

Chattem, Inc.

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:4116 7-1740 -2

113 mL in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

0 6 /0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part348

0 6 /0 1/20 19

Labeler -

Chattem, Inc. (003336013)

Revised: 6/2019

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